ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),; CATHETER, STEERABLE
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Model Number 401932 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 05/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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An event of pericardial effusion was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Event Description
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Related manufacturer report numbers: 3005334138-2020-00194, 3005334138-2020-00195, 2182269-2020-00045.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Isolation of the left pulmonary veins was achieved.After isolating the right veins, the patient became hypotensive and ice was used to identify a pericardial effusion.A pericardialcentesis was performed to stabilize the patient.There were no performance issues with abbott devices.
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Search Alerts/Recalls
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